Senior Mechanical Engineer - NPD for China Localization

Primary Function of the Position Intuitive Surgical (ISI) has established a preeminent position in surgical robotics with a presence in more than 60 countries around the world. China represents a key market to Intuitive that has unprecedented growth opportunities driven largely by unmet patient and disease needs. A Joint Venture (JV) between ISI and Fosun Pharma – a subsidiary of Fosun International, a leading Pharma and Medical Device Company in China – has been established to accelerate the opportunities within this key market. The intent of the JV is to research, develop, and manufacture innovative, robotic-assisted medical devices. The Senior Mechanical Engineer is responsible for supporting Intuitive Surgical and JV’s New Product Development (NPD) team focused on the development, localization, and launch of various robotic-assisted platforms in China. Essential Job Duties Become intimately familiar with all technical and documentation aspects for a robotic platform product line. Be a direct technical contributor for development activities related to product launch in China, including creating design input documents, developing test methods, executing design verification testing, and preparing technical submission dossiers Partner with product development teams and NRTLs (Nationally Recognized Test Labs) to achieve product certification and regulatory approvals per project timelines. Work closely with design teams and project management to proactively mitigate risk from compliance issues through proactive participation in design reviews and early compliance testing of prototypes. Familiarity with all phases of the product development lifecycle and ensure Design Control processes are followed per relevant internal procedures & external regulations Required Skills and Experience Strong understanding of design for reliability, robustness, and manufacturing. Proficiency using CAD to design and document mechanisms; SolidWorks preferred Self-motivated, hands-on, and the ability to work well within a fast-paced team-oriented environment. Ability to handle ambiguity and adapt to changes effectively and oversee multiple projects at once Excellent communication (written, verbal), presentation and documentation skills Required Education and Training Minimum of eight (8) years of experience with a bachelor’s degree in mechanical engineering or six (6) years of experience with a master’s degree. Working Conditions Ability to travel up to 10% of the time. Preferred Skills and Experience Knowledge of experience in China regulations, technical guidelines, and submission pathway Strong analysis skills, and knowledge of engineering tools that drive design excellence Experience transferring manufacturing lines to remote sites a strong plus Experience with submitting med devices to regulatory agency, like NMPA, a strong plus Fluent in English and Mandarin (read/write) a strong plus Broad and deep understanding of Requirement Management and Medical Devices Design Controls regulations (FDA CFR/QSIT, MDR, ISO 13485, ISO 14971, NMPA) Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. Mandatory Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee. This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate’s experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law. We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.